Failure Modes and Effects Analysis - Quality Management...
Transcript of Failure Modes and Effects Analysis - Quality Management...
FAILURE MODES AND
EFFECTS ANALYSIS
Ms Rawia A Abdalla RN MSN CPHQ CPPS
Head of Patient Safety Unit
OUTLINE
Definitions
Benefits of FMEA
History of FMEA
When to use FMEA
What does FMEA include
Steps in FMEA
Common mistakes in FMEA
WHAT COULD GO WRONG
WHAT COULD GO
WRONG
Medication Prescription
Surgical procedure
Blood transfusion
FAILURE MODES AND EFFECTS ANALYSIS
Failure Modes
The ways or modes in which something might fail
It is a concise description of how a part of a process
may potentially fail to perform its functions
( Prescription errors wrong dose route or infusion time
Proper patient monitoring not ordered Prescribed on wrong patient No order received Illegible writing )
Effect Analysis
Studying the consequences of those failures
Failures are prioritized according to its frequency
and seriousness
DEFINITION
Failure Modes and Effects Analysis (FMEA)
is a systematic proactive method for evaluating a
process to identify where and how it might fail
and to assess the relative impact of different
failures in order to identify the parts of the
process that are most in need of change
(Institute of Healthcare Improvement 2004)
Preventing problems is cheaper and easier than
cleaning them up
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
OUTLINE
Definitions
Benefits of FMEA
History of FMEA
When to use FMEA
What does FMEA include
Steps in FMEA
Common mistakes in FMEA
WHAT COULD GO WRONG
WHAT COULD GO
WRONG
Medication Prescription
Surgical procedure
Blood transfusion
FAILURE MODES AND EFFECTS ANALYSIS
Failure Modes
The ways or modes in which something might fail
It is a concise description of how a part of a process
may potentially fail to perform its functions
( Prescription errors wrong dose route or infusion time
Proper patient monitoring not ordered Prescribed on wrong patient No order received Illegible writing )
Effect Analysis
Studying the consequences of those failures
Failures are prioritized according to its frequency
and seriousness
DEFINITION
Failure Modes and Effects Analysis (FMEA)
is a systematic proactive method for evaluating a
process to identify where and how it might fail
and to assess the relative impact of different
failures in order to identify the parts of the
process that are most in need of change
(Institute of Healthcare Improvement 2004)
Preventing problems is cheaper and easier than
cleaning them up
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
WHAT COULD GO WRONG
WHAT COULD GO
WRONG
Medication Prescription
Surgical procedure
Blood transfusion
FAILURE MODES AND EFFECTS ANALYSIS
Failure Modes
The ways or modes in which something might fail
It is a concise description of how a part of a process
may potentially fail to perform its functions
( Prescription errors wrong dose route or infusion time
Proper patient monitoring not ordered Prescribed on wrong patient No order received Illegible writing )
Effect Analysis
Studying the consequences of those failures
Failures are prioritized according to its frequency
and seriousness
DEFINITION
Failure Modes and Effects Analysis (FMEA)
is a systematic proactive method for evaluating a
process to identify where and how it might fail
and to assess the relative impact of different
failures in order to identify the parts of the
process that are most in need of change
(Institute of Healthcare Improvement 2004)
Preventing problems is cheaper and easier than
cleaning them up
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
WHAT COULD GO
WRONG
Medication Prescription
Surgical procedure
Blood transfusion
FAILURE MODES AND EFFECTS ANALYSIS
Failure Modes
The ways or modes in which something might fail
It is a concise description of how a part of a process
may potentially fail to perform its functions
( Prescription errors wrong dose route or infusion time
Proper patient monitoring not ordered Prescribed on wrong patient No order received Illegible writing )
Effect Analysis
Studying the consequences of those failures
Failures are prioritized according to its frequency
and seriousness
DEFINITION
Failure Modes and Effects Analysis (FMEA)
is a systematic proactive method for evaluating a
process to identify where and how it might fail
and to assess the relative impact of different
failures in order to identify the parts of the
process that are most in need of change
(Institute of Healthcare Improvement 2004)
Preventing problems is cheaper and easier than
cleaning them up
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FAILURE MODES AND EFFECTS ANALYSIS
Failure Modes
The ways or modes in which something might fail
It is a concise description of how a part of a process
may potentially fail to perform its functions
( Prescription errors wrong dose route or infusion time
Proper patient monitoring not ordered Prescribed on wrong patient No order received Illegible writing )
Effect Analysis
Studying the consequences of those failures
Failures are prioritized according to its frequency
and seriousness
DEFINITION
Failure Modes and Effects Analysis (FMEA)
is a systematic proactive method for evaluating a
process to identify where and how it might fail
and to assess the relative impact of different
failures in order to identify the parts of the
process that are most in need of change
(Institute of Healthcare Improvement 2004)
Preventing problems is cheaper and easier than
cleaning them up
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
DEFINITION
Failure Modes and Effects Analysis (FMEA)
is a systematic proactive method for evaluating a
process to identify where and how it might fail
and to assess the relative impact of different
failures in order to identify the parts of the
process that are most in need of change
(Institute of Healthcare Improvement 2004)
Preventing problems is cheaper and easier than
cleaning them up
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
WHAT IF YOU
STOPPED
GOING
OUTSIDE
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
BENEFITS
Get it right the first time
Identify any inadequacies in the process
Continuous improvement
Team building
Reduce the likelihood of complications
Reduce maintenance costs
Reduce the possibility of safety failures
Greater customer satisfaction and reduced
complaints
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
WHEN TO USE FMEA
FMEA should be used
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
HISTORY OF FMEA Developed in the US Military 1949 titled Procedures for
Performing a Failure Mode Effects and Criticality Analysis Failures were classified according to their impact on mission success and
personnelequipment safety
Formally developed and applied by NASA in the 1960rsquos to improve
and verify reliability of space program hardware during the Apollo
program
Initial automotive adoption (Ford)
in the 1970rsquos
Automotive Industry Action Group and
American Society for Quality Control
copyright standards in 1993
Now adopted by many other industries
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2006
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2007
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2011
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2011
PCA Over-sedation Application Of
Healthcare Failure Mode Effect Analysis
(HFMEAtrade)
Pam Cronrath MN RN Timothy W Lynch PharmD MS FABC Linda J Gilson BSN RN
CAPA Carol Nishida BSN RN CMSRN M Colleen Sembar MSM BSN RN CCRN Patricia J
Spencer BSN RN BC ONC Daidre Foote West BSN RN CPUM
The changes implemented identified 16 failure
points with a hazard score of 16 or greater One
year later the established system HFMEA goal
was met Reduce oversedation events by 50
fiscal year end 2008
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2012
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
FMEA IN THE LITERATURE
2013 - ONLINE
Health Care Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream Infections
Celeste J Chandonnet RN BSN CCRNabPrerna S Kahlon BDS MPAH CPHQc Pratik Rachh MD MBA CQPA CPHQd Michele DeGrazia PhD RN NNP-BCabe Eileen C DeWitt RNC MS NNP-BCab Kathleen A Flaherty MT(ASCP) BS CICab Nadine Spigel RN BSN CCRNab Stephanie Packard RN BSN CCRNab Denise Casey MS RN CCRN CPNPab Christine Rachwal MSN RN CCRNab and Pankaj B Agrawal MD MMSCace
Since implementing the appropriate action plans the NICU has experienced a significant decrease in CLABSIs from 26 to 08 CLABSIs per 1000 line days
The process of HFMEA helped reduce the CLABSI rate and reinforce the culture of continuous quality improvement and safety in the NICU
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
WHAT DOES FMEA INCLUDE
FMEA includes review of the following
Steps in the process
Failure modes (What could go wrong)
Failure causes (Why would the failure happen)
Failure effects (What would be the consequences
of each failure)
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEPS OF FMEA
1 Select a process to evaluate with FMEA
2 Recruit a multidisciplinary team
3 Review the process
4 List failure modes and causes and its effect on
patients
5 Assign Risk Code
6 Evaluate the results
7 Create actions to reduce risks
8 Assign responsibility for actions
9 Re-assign risk codes (residual risk)
10 Monitor the actions and risk reduction
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 1
SELECT A PROCESS TO EVALUATE WITH FMEA
Evaluation using FMEA works best on processes that do not have too many sub processes
Instead of doing FMEA on a large and complex process such as medication management in a hospital try doing an FMEA on sub processes like medication ordering dispensing or administration processes
Select processes with high risk high cost high volume or with wide variation in practice
Process Medication prescription by the physician
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 2
RECRUIT A MULTIDISCIPLINARY TEAM
Be sure to include everyone who is involved at any point in the process
Some people may not need to be part of the team throughout the entire analysis but they should certainly be included in discussions of those steps in the process in which they are involved
For example if you want to evaluate VAP prevention you will include pulmonologists respiratory therapy infection control pharmacy nursing
Process Medication prescription by the physician
Team Physician nursing pharmacy
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 3
REVIEW THE PROCESS
It may take several meetings for the team to complete
this part of the FMEA depending on the number of
steps and the complexity of the process
Flowcharting can be a helpful tool for outlining the
steps
When you are finished be sure to obtain consensus
from the group
The team should agree that the steps enumerated in
the FMEA accurately describe the process
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
GRAPHICAL REPRESENTATION
Medication Management
1 Prescription 11 Physician checks results
12 Physician prescribes medication
2 Dispensing
21 Send order to pharmacy
22 Enter order into computer
23 Produce label
24 Prepare medication
25 Check medication before distribution
26 Deliver medication to the units
3 Administration
31 Receive order and transcribe onto medication record
32 Obtain infusion pump
33 Obtain medication
34 Program infusion pump
35 Check medicaition pump settings before administration
36 Administer medication
37 Document administration
38 Monitor side effects adverse events
4 Laboratory Monitoring
41 Laboratory request
42 Serum blood sample
43 label sample
44 Send to the laboratory
45 Checking results by nurses
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 4
LIST FAILURE MODES AND CAUSES AND ITS
EFFECT ON PATIENTS
For each step in the process list all possible
―failure modesmdashthat is anything that could go
wrong including minor and rare problems
For each failure mode listed identify all possible
causes
Then for each failure mode listed identify all
possible effects
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
Sub process Failure Modes Failure causes Failure Effect
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal and
endocrine functions
allergy seizures cardiac
rhythm) concomitant use
of oral drugs knowledge
deficit mental slip
information on drug not
available
Overdose under-dose
improper route
selection ADR allergic
response prolonged
infusion time leads to
delay in therapy very
fast infusion leads to
side effects
Proper patient
monitoring not
ordered
Knowledge deficit mental
slip
Failure to detect
problems early to
prevent harm
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient receives
inappropriate drug and
dose ADR allergic
response
No order received Unable to reach on call
physician
Poor patient
management
Illegible writing
(use abbreviations
unclear hand
writing )
Knowledge deficit mental
slip no list of approved
abbreviations
Wrong drug Overdose
under-dose improper
route selection ADR
allergic response delay
in treatment
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 5
ASSIGN RISK CODE
Risk Code = Severity X Occurrence
Severity (1= Minimum 5 = Serious)
If this failure mode occurs how likely is it that
harm will occur
Probability of occurrence (1 = Rare 5 = Frequent)
How likely is it that this failure mode will occur
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
5 X 5 HAZARD SCORING MATRIX
Failure modes with higher hazard scores should
receive the highest priority
Severity
Probability Serious
(5)
Major
(4)
Moderate
(3)
Minor
(2)
Minimum
(1)
Frequent (5) 25 20 15 10 5
Likely (4) 20 16 12 8 4
Possible (3) 15 12 9 6 3
Unlikely (2) 10 8 6 4 2
Rare (1) 5 4 3 2 1
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
Sub process Failure Modes Failure causes Failure Effect S P Hazard
Physician
prescribes
medication
Wrong dose route
or infusion time
(fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip information
on drug not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6
No order received Unable to reach on call
physician
Poor patient
management
2 2 4
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 6
EVALUATE THE RESULTS
Hazard scores
1= Low risk 25 = Extreme risk
Failure modes with higher hazard scores should
receive the highest priority and should trigger
consideration of potential action to control the
failure
These are the ones the team should consider first
as improvement opportunities
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 7
CREATE ACTIONS TO REDUCE RISKS
Evaluate the causes and see if any or all of them
can be eliminated
Modify other processes that contribute to causes
Actions Control Measures
1 Engineering structural control
(Reconstruction anti slippery floors hood)
2 Administrative changes
(policies protocols job descriptions)
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions
Physician
prescribes
medication
Wrong dose
route or infusion
time (fast slow)
Clinical situation not
considered (age renal
and endocrine
functions allergy
seizures cardiac
rhythm) concomitant
use of oral drugs
knowledge deficit
mental slip
information on drug
not available
Overdose under-
dose improper route
selection ADR
allergic response
prolonged infusion
time leads to delay in
therapy very fast
infusion leads to side
effects
4 4 16 Clinical pharmacy
program pre-printed
medications protocol
with education on
use easy access to
drug information
feedback mechanism
on substitute drugs
available
Proper patient
monitoring not
ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication protocols
with monitoring
guidelines
Prescribed on
wrong patient
Similar patient names
patient identifier not
clear no identifier
verification
Wrong patient
receives
inappropriate drug
and dose ADR
allergic response
3 2 6 Match result to
patient condition
alert for a look-alike
patient names visible
demographics on
identifier
No order
received
Unable to reach on call
physician
Poor patient
management
2 2 4 Proper physician
coverage and
communication
channels
Illegible writing
(use
abbreviations
unclear hand
writing )
Knowledge deficit
mental slip no list of
approved
abbreviations
Wrong drug
Overdose under-
dose improper route
selection ADR
allergic response
delay in treatment
4 4 16 pre-printed
medication protocol
Health Information
Systems list of
approved
abbreviations
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 8
ASSIGN RESPONSIBILITY FOR ACTIONS
Assign responsibilities for implementing the
corrective and preventive actions
Set timelines determine the project completion
dates
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 9
RE-ASSIGN RISK CODES (RESIDUAL RISK)
Determine what is the risk code after
implementing the actions for each failure mode
The aim is to assist the team in prioritizing
actions and to determine if actions were effective
or not
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
Sub process Failure Modes Failure causes Failure Effect S P Hazard Actions Responsibility S P Hazard
Physician
prescribes
medication
Wrong dose
route or
infusion time
(fast slow)
Clinical situation
not considered
(age renal and
endocrine
functions allergy
seizures cardiac
rhythm)
concomitant use of
oral drugs
knowledge deficit
mental slip
information on
drug not available
Overdose under-
dose improper
route selection
ADR allergic
response
prolonged
infusion time
leads to delay in
therapy very fast
infusion leads to
side effects
4 4 16 Clinical pharmacy
program pre-
printed
medications
protocol with
education on use
easy access to
drug information
feedback
mechanism on
substitute drugs
available
XXXXXXX 2 2 4
Proper
patient
monitoring
not ordered
Knowledge deficit
mental slip
Failure to detect
problems early to
prevent harm
4 3 12 pre-printed
medication
protocols with
monitoring
guidelines
XXXXXXX 2 3 6
Prescribed on
wrong patient
Similar patient
names patient
identifier not clear
no identifier
verification
Wrong patient
receives
inappropriate
drug and dose
ADR allergic
response
3 2 6 Match result to
patient condition
alert for a look-
alike patient
names visible
demographics on
identifier
XXXXXXX 1 1 1
No order
received
Unable to reach on
call physician
Poor patient
management 2 2 4 Proper physician
coverage and
communication
channels
XXXXXXX 1 1 1
Illegible
writing (use
abbreviations
unclear
hand writing)
Knowledge deficit
mental slip no list
of approved
abbreviations
Wrong drug
Overdose under-
dose improper
route selection
ADR allergic
response delay
in treatment
4 4 16 pre-printed
medication
protocol Health
Information
Systems list of
approved
abbreviations
XXXXXXX 3 4 12
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
STEP 10
MONITOR THE ACTIONS AND RISK REDUCTION
Monitor to evaluate if the risk reduction
strategies have reduced risk and take additional
actions if necessary to further reduce risk
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
USES OF FMEA
Use FMEA to plan actions to reduce harm from failure modes
Use FMEA to evaluate the potential impact of changes under consideration ( check the residual risk code)
Use FMEA to monitor and track improvement over time by calculating a risk code for the process and then set a goal for improvement
For example a team may set a goal of decreasing the risk code for the medication ordering process by 50 from the baseline
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
Phase 1 Phase 2 Phase 3
Processes amp
sub processes
Potential
Failure modes
Potential
Causes
Potential Effects
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
Recommended Actions Responsibility
and target date
Seve
rity
Sco
re
Pro
bab
ility
Sco
re
Haz
ard
sco
re
1 Process
11 Sub-process
12 Sub-process
13 Sub-process
14 Sub-process
15 Sub-process
2 Process
21 Sub-process
22 Sub-process
23 Sub-process
24 Sub-process
25 Sub-process
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
COMMON MISTAKES IN FMEA
The quality department is the owner of FMEA
The wrong people are selected to participate in the
sessions of FMEA inadequate team composition
The FMEA are done at a wrong time
The FMEA provides the wrong level of detail
(missing the high risk areas or the root causes)
Failure to drive any design or process improvement
Failure to address all high risk failure modes
Failure to produce action and control plans
Improper FMEA procedure
Lack of efficient use of time in the meetings
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
ADDITIONAL RESOURCES
Please Visit the Institute for Healthcare
Improvement (IHI) Website to see an
interactive FMEA Tool available on IHIorg
PREVENTIVE MEDICINE IS
LESS COSTLY THAN
CURATIVE MEDICINE
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969
REFERENCES
Institute for Healthcare Improvement 2004 Failure Modes and Effects Analysis
(FMEA)
Kimchi-Woods J Shultz J (2006) Using HFMEA to Assess Potential for Patient
Harm from Tubing Misconnections Journal on quality and patient safety 32 (7) 373-
381
Kathy Ouellette-Piazzo K Asfaw M amp Cowen J (2007) CT Healthcare Failure
Mode Effect Analysis (HFMEAreg) The Misadministration of IV Contrast in
Outpatients Radiology management 29 (1) 36-44
Ashley L Dexter R Marshall F McKenzie B Ryan M amp Armitage G (2011)
Improving the Safety of Chemotherapy Administration An Oncology Nurse-Led
Failure Mode and Effects Analysis Oncology Nursing Forum 38 (6) E436 ndash E444
STEELMAN M amp CULLEN J (2011) Designing a Safer Process to Prevent
Retained Surgical Sponges A Healthcare Failure Mode and Effect Analysis AORN
Journal 94 (2) 132-141
Cronrath P Lynch TW Gilson LJ Nishida C Sembar MC Spencer PJ West DF
(2011) PCA oversedation application of Healthcare Failure Mode Effect (HFMEA)
Analysis Nursing economics 29(2) 79-87
Cheng C Chou CH Wang PC Lin HY Kao CL Su CT (2012) Applying
HFMEA to Prevent Chemotherapy Errors Journal of medical systems 36 1543-
1551
Chandonnet C Kahlon P Rachh P DeGrazia M DeWitt E Flaherty K
Spigel N Packard S Casey D Rachwal C Agrawal P (2013) Health Care
Failure Mode and Effect Analysis to Reduce NICU LinendashAssociated Bloodstream
Infections Pediatrics 131(6) 1961-1969